Antidepressants in Children

Weighing the Risks

Studies show that there are substantial benefits from the medications used to treat adolescents with moderate and severe depression, including those with suicidal thoughts. But all treatments can be associated with side effects. A careful weighing of the risks and benefits, with appropriate monitoring to help reduce these risks, is the best that can be currently recommended.

Understanding How Medicines Are Approved

Many people wonder, "What difference does it make if a medication is specifically approved for use in children or not?" Approval of a medication by the FDA means that adequate data have been provided to the FDA by the drug manufacturer to show safety and effectiveness for a particular therapy in a particular population. Based on the data, a label indication for the drug is established that includes proper dosage, potential side effects, and approved age.
Doctors prescribe medications as they feel appropriate, even if those uses are not included in the labeling. Although in some cases there is extensive clinical experience in using medications for children or adolescents, in many cases there is not. Everyone agrees that more studies in children are needed if we are to know the appropriate dosages, how a drug works in children, and what possible effects there may be on learning and development.

Children and Off-Label Antidepressants

Many medications that are on the market have not been officially approved by the FDA for use in children. Treatment of children with these medications is called "off-label" use. For some medications, the off-label use is supported by data from well-conducted studies in children. For instance, some antidepressant medications have been shown to be effective in children and adolescents with depression.
For other medications, there have been no controlled studies in children, but only isolated clinical reports. In particular, the use of psychotropic medications in preschoolers has not been adequately studied and must be considered very carefully by balancing severity of symptoms, degree of impairment, and potential benefits and risks of treatment.
In the past, medications were not studied in children because of ethical concerns about involving children in clinical trials. However, this created a new problem: lack of knowledge about the best treatments for children. In clinical settings where children are suffering from mental or behavioral disorders, medications are being prescribed at increasingly early ages. The FDA has been urging that products be appropriately studied in children and has offered incentives to drug manufacturers to carry out such testing.
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Depression in Children

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